5 Contamination Hot Spots - METTLER TOLEDO

5 Contamination Hot Spots

Improve cleaning effectiveness and efficiency in pharmaceutical manufacturing with hygienically designed weighing equipment

Cross-contamination in drug manufacturing impacts product quality and may even lead to product recalls. Hygienically designed weighing equipment helps prevent cross-contamination and ensures regulatory compliance.

In pharmaceutical manufacturing, a range of regulations and industrial standards provide guidance to help ensure product safety and efficacy. With regard to equipment design and use in pharmaceutical manufacturing processes, the leading authorities, such as FDA, WHO, EMA or ICH are very consistent in their Good Manufacturing Practice (GMP) guidance, stating that equipment should be designed for its intended use, prevent contamination of the drug product and facilitate easy cleaning.

Which parts of the scale pose the most risk?

Sanitary standards, as defined by EHEDG and NSF, include a wide range of equipment design aspects, such as selecting the right construction materials, providing easy access for cleaning and preventing the accumulation of materials and liquids.

When selecting weighing equipment that helps ensure regulatory compliance, pay attention to the high risk areas for contamination: equipment surface, weldings, sealings, threads, fasteners and any inaccessible areas.

A rough equipment surface, stitch welding and certain types of sealings facilitate the accumulation of contaminants and microorganisms. Corners and angles with less than a 90° radius are difficult to clean, along with any inaccessible areas. Threads and fasteners provide dead areas which are difficult to reach and pose a contamination risk.

5 Contamination Hot Spots

How does a properly designed scale facilitate cleaning and maintenance?

In regards to the equipment surface, the construction materials must be corrosion resistant, non-toxic and non-absorbent. Surface roughness should be below 0.81 micrometer to prevent the accumulation of micro-organisms. A properly designed scale will be made with high-quality stainless steel, AISI 304 or 316 grade, that has been electro-polished or glass bead blasted for a smooth surface.

The construction of weighing equipment sealing should be open and easily accessible with continuous, polished and smooth welding. Horizontal elements should be rounded and dead spaces and hollow areas avoided. Internal corners and angles should be rounded and have at least a 90° radius. An easily-removable weighing platform and minimal horizontal surfaces allow for cleaning access and the prevention of material accumulation.

Other elements of a hygienically designed scale are a protected load cell, hygienic foot design, terminal protection and hidden cables.

To learn more about preventing cross-contamination, complying with regulations and improving cleaning efficiency in pharmaceutical manufacturing, download the brochure: Effective and Efficient Cleaning of Pharma Weighing Solutions.

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